LIAISON Quantiferon TB Gold Plus

GUDID 08056771103268

DIASORIN SPA

Interferon IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 08056771103268
• NIH Device Record Key: 65dd5b0a-7c48-4c5a-bbca-b45d2bf386f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LIAISON Quantiferon TB Gold Plus
• Version Model Number: 311020
• Company DUNS: 630822989
• Company Name: DIASORIN SPA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 651-439-9710
• Email: info@diaSorin.com
• Phone: 651-439-9710
• Email: info@diaSorin.com
• Phone: 651-439-9710
• Email: info@diaSorin.com
• Phone: 651-439-9710
• Email: info@diaSorin.com
• Phone: 651-439-9710
• Email: info@diaSorin.com
• Phone: 651-439-9710
• Email: info@diaSorin.com
• Phone: 651-439-9710
• Email: info@diaSorin.com
• Phone: 651-439-9710
• Email: info@diaSorin.com
• Phone: 651-439-9710
• Email: info@diaSorin.com
• Phone: 651-439-9710
• Email: info@diaSorin.com
• Phone: 651-439-9710
• Email: info@diaSorin.com
• Phone: 651-439-9710
• Email: info@diaSorin.com
• Phone: 651-439-9710
• Email: info@diaSorin.com
• Phone: 651-439-9710
• Email: info@diaSorin.com
• Phone: 651-439-9710
• Email: info@diaSorin.com
• Phone: 651-439-9710
• Email: info@diaSorin.com
• Phone: 651-439-9710
• Email: info@diaSorin.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08056771103268 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P180047

FDA Product Code

• NCD: Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-17
• Device Publish Date: 2019-12-09

On-Brand Devices [LIAISON Quantiferon TB Gold Plus]

• 08056771103268: 311020
• 08056771603300: 311040
• 08056771104081: Italy manufactured kit.
• 08056771104098: Italy manufactured kit.